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出境医 / 临床实验 / Bariatric Surgery and LDL Cholesterol (BASALTO)

Bariatric Surgery and LDL Cholesterol (BASALTO)

Study Description
Brief Summary:

Background:

Observational studies have shown that gastric bypass is superior to sleeve gastrectomy in terms of LDL cholesterol improvement. If these results are confirmed in randomized controlled trials, pre-surgical LDL cholesterol status should be a point to consider in the surgical procedure election.

Objective:

The primary objective is to compare 1-year LDL cholesterol remission after gastric bypass and sleeve gastrectomy in morbid obese patients.

Methods:

Phase 3, uni-centric, randomized clinical trial, with intention-to-treat analysis to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy with a 12 months follow-up. The inclusion criteria will be patients aged between 18-60 years old with a body mass index ≥40 or ≥35 kg/m2 with a significant obesity related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively (2 months before surgery) and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measures, food intake recall, physical activity questionnaires,intima media thickness, fecal samples for microbiota examinations, fat tissue samples and serum samples for lipidomics and hormonal analyses.


Condition or disease Intervention/treatment Phase
Bariatric Surgery Procedure: Gastric bypass Procedure: Sleeve gastrectomy Not Applicable

Detailed Description:

In the preoperative period, patients will follow a standard nutritional intervention that includes 6 monthly group sessions focused on achieving changes in dietary habits and hence ease adaptation after surgery.

In addition, lipid-lowering treatment will be adjusted and standardized following the Institut Català de la Salut clinical practice guidelines. Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.

After surgery, a standardized protocol will be followed for the two groups in relation to dietary recommendations and physical activity, as well as the initiation of lipid-lowering medication after the intervention, in order to avoid the bias that may arise due to an open study.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The researcher responsible for statistical analysis will be blinded to group allocation until data analysis is complete.
Primary Purpose: Treatment
Official Title: BASALTO (Bariatric Surgery and LDL Cholesterol) Trial
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Gastric bypass
Bariatric surgery by gastric bypass (GB)
 Procedure: Gastric bypass
The GB technique consists of a 150-cm antecolic Roux limb with a 25-mm circular pouch-jejunostomy and exclusion of 50 cm of the proximal jejunum.
Experimental: Sleeve gastrectomy
Bariatric surgery by sleeve gastrectomy (SG)
 Procedure: Sleeve gastrectomy
The SG technique consists of a longitudinal resection of the stomach from the angle of His to approximately 5 cm proximal to the pylorus, using a 35 French bougie inserted along the lesser curvature.
Outcome Measures
Primary Outcome Measures :
  1. LDL cholesterol remission 1 year after GB and SG [ Time Frame: At 12 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs


Secondary Outcome Measures :
  1. LDL cholesterol remission at 3 months after GB and SG [ Time Frame: At 3 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs

  2. LDL cholesterol remission at 6 months after GB and SG [ Time Frame: At 6 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs

  3. LDL cholesterol improvement postoperatively [ Time Frame: At 12 months after surgery ]

    In patients without preoperative cholesterol lowering drugs: Decrease ≥20% in LDL cholesterol concentration (mg/dL) without cholesterol-lowering drugs.

    In patients with preoperative cholesterol lowering drugs: Medication withdrawn and LDL cholesterol >130 mg/dL, or decrease ≥20% in LDL cholesterol concentration without medication withdrawn.


  4. Hypertriglyceridemia remission postoperatively [ Time Frame: 12 months after surgery ]
    Triglyceride concentration <150 mg/dL without fibrates

  5. Low HDL cholesterol remission postoperatively [ Time Frame: 12 months after surgery ]
    HDL cholesterol concentration >50 mg/dL in women, or >40 mg/dL in men

  6. Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 3 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

  7. Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 6 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

  8. Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 12 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

  9. Changes in total cholesterol during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

  10. Changes in total cholesterol during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

  11. Changes in total cholesterol during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

  12. Changes in HDL cholesterol during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

  13. Changes in HDL cholesterol during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

  14. Changes in HDL cholesterol during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

  15. Changes in triglycerides during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

  16. Changes in triglycerides during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

  17. Changes in triglycerides during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

  18. Changes in lipoprotein(a) during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

  19. Changes in lipoprotein(a) during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

  20. Changes in lipoprotein(a) during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

  21. Changes in lipoproteins particle size [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

  22. Changes in lipoproteins composition [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

  23. Changes in lipoproteins particle size [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

  24. Changes in lipoproteins composition [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

  25. Changes in lipoproteins particle size [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

  26. Changes in lipoproteins composition [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

  27. Change in patients' estimated cardiovascular risk [ Time Frame: At 3 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

  28. Change in patients' estimated cardiovascular risk [ Time Frame: At 6 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

  29. Change in patients' estimated cardiovascular risk [ Time Frame: At 12 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

  30. Type 2 diabetes complete remission [ Time Frame: At 3 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications

  31. Type 2 diabetes complete remission [ Time Frame: At 6 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications

  32. Type 2 diabetes complete remission [ Time Frame: At 12 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications

  33. Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 3 months postoperatively ]
    Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones

  34. Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 6 months postoperatively ]
    Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones

  35. Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 12 months postoperatively ]
    Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones

  36. Changes in intima media thickness [ Time Frame: At 12 months postoperatively ]
    Variation of mean intima-media thickness (IMT, in mm) measured ultrasonographically in the far wall of bilateral common carotid arteries with respect to preoperative value


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) ≥40 or BMI ≥35 kg/m2 with a significant obesity related comorbidities.
  • Age 18 - 60 years.
  • Previous successfully instituted and supervised but failed adequate diet and exercise program.
  • Elevated LDL cholesterol defined as LDL cholesterol concentration >130 mg/dL or treatment with cholesterol-lowering drugs.

Exclusion Criteria:

  • BMI >60 kg/m2.
  • Previous BS.

  • Exclusion criteria for BS:

    • Significant psychiatric disorder.
    • Severe eating disorder, active alcohol or substance abuse.
    • Contraindications for major abdominal surgery.
    • Active gastric ulcer disease.
    • Severe hepatic diseases.
    • Pregnancy or breastfeeding.

  • Cases in whom SG or GB are preferred:

    • Severe symptomatic gastro esophageal reflux disease despite medication.
    • Large hiatal hernia.
    • Expected dense adhesions at the level of the small bowel.
    • Need for endoscopic follow-up of the duodenum, history of inflammatory bowel disease.
    • History of renal transplantation in which drug malabsorption can be caused with a GB.

  • Cholesterol lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up. Cases in whom perioperative statins withdrawn cannot be adequate will be excluded:

    • Established cardiovascular disease or subclinical cardiovascular disease (atheroma plaque detection in carotid ultrasonography exam) in which LDL cholesterol objectives are more aggressive or statins can be prescribed independently of LDL cholesterol levels.
    • LDL cholesterol >190 mg/dL or history of familial hypercholesterolemia.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: David Benaiges Boix, Dr +34932483902 DBenaiges@parcdesalutmar.cat

Locations
Layout table for location information
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: David Benaiges Boix, Dr    +34932483902    DBenaiges@parcdesalutmar.cat   
Principal Investigator: David Benaiges Boix, Dr         
Sub-Investigator: Albert Goday Arnó, Dr         
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Layout table for investigator information
Principal Investigator: David Benaiges Boix, Dr Hospital del Mar (Barcelona, Spain)
Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE July 23, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019) 		LDL cholesterol remission 1 year after GB and SG [ Time Frame: At 12 months after surgery ]
Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • LDL cholesterol remission at 3 months after GB and SG [ Time Frame: At 3 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs
  • LDL cholesterol remission at 6 months after GB and SG [ Time Frame: At 6 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs
  • LDL cholesterol improvement postoperatively [ Time Frame: At 12 months after surgery ]
    In patients without preoperative cholesterol lowering drugs: Decrease ≥20% in LDL cholesterol concentration (mg/dL) without cholesterol-lowering drugs. In patients with preoperative cholesterol lowering drugs: Medication withdrawn and LDL cholesterol >130 mg/dL, or decrease ≥20% in LDL cholesterol concentration without medication withdrawn.
  • Hypertriglyceridemia remission postoperatively [ Time Frame: 12 months after surgery ]
    Triglyceride concentration <150 mg/dL without fibrates
  • Low HDL cholesterol remission postoperatively [ Time Frame: 12 months after surgery ]
    HDL cholesterol concentration >50 mg/dL in women, or >40 mg/dL in men
  • Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 3 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 6 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 12 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in total cholesterol during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in total cholesterol during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in total cholesterol during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in HDL cholesterol during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in HDL cholesterol during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in HDL cholesterol during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
  • Changes in triglycerides during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value
  • Changes in triglycerides during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value
  • Changes in triglycerides during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value
  • Changes in lipoprotein(a) during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
  • Changes in lipoprotein(a) during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
  • Changes in lipoprotein(a) during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
  • Changes in lipoproteins particle size [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value
  • Changes in lipoproteins composition [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
  • Changes in lipoproteins particle size [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value
  • Changes in lipoproteins composition [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
  • Changes in lipoproteins particle size [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value
  • Changes in lipoproteins composition [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
  • Change in patients' estimated cardiovascular risk [ Time Frame: At 3 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
  • Change in patients' estimated cardiovascular risk [ Time Frame: At 6 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
  • Change in patients' estimated cardiovascular risk [ Time Frame: At 12 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
  • Type 2 diabetes complete remission [ Time Frame: At 3 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications
  • Type 2 diabetes complete remission [ Time Frame: At 6 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications
  • Type 2 diabetes complete remission [ Time Frame: At 12 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications
  • Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 3 months postoperatively ]
    Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones
  • Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 6 months postoperatively ]
    Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones
  • Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 12 months postoperatively ]
    Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones
  • Changes in intima media thickness [ Time Frame: At 12 months postoperatively ]
    Variation of mean intima-media thickness (IMT, in mm) measured ultrasonographically in the far wall of bilateral common carotid arteries with respect to preoperative value
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bariatric Surgery and LDL Cholesterol
Official Title  ICMJE BASALTO (Bariatric Surgery and LDL Cholesterol) Trial
Brief Summary

Background:

Observational studies have shown that gastric bypass is superior to sleeve gastrectomy in terms of LDL cholesterol improvement. If these results are confirmed in randomized controlled trials, pre-surgical LDL cholesterol status should be a point to consider in the surgical procedure election.

Objective:

The primary objective is to compare 1-year LDL cholesterol remission after gastric bypass and sleeve gastrectomy in morbid obese patients.

Methods:

Phase 3, uni-centric, randomized clinical trial, with intention-to-treat analysis to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy with a 12 months follow-up. The inclusion criteria will be patients aged between 18-60 years old with a body mass index ≥40 or ≥35 kg/m2 with a significant obesity related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively (2 months before surgery) and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measures, food intake recall, physical activity questionnaires,intima media thickness, fecal samples for microbiota examinations, fat tissue samples and serum samples for lipidomics and hormonal analyses.
Detailed Description

In the preoperative period, patients will follow a standard nutritional intervention that includes 6 monthly group sessions focused on achieving changes in dietary habits and hence ease adaptation after surgery.

In addition, lipid-lowering treatment will be adjusted and standardized following the Institut Català de la Salut clinical practice guidelines. Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.

After surgery, a standardized protocol will be followed for the two groups in relation to dietary recommendations and physical activity, as well as the initiation of lipid-lowering medication after the intervention, in order to avoid the bias that may arise due to an open study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The researcher responsible for statistical analysis will be blinded to group allocation until data analysis is complete.
Primary Purpose: Treatment
Condition  ICMJE Bariatric Surgery
Intervention  ICMJE
  • Procedure: Gastric bypass
    The GB technique consists of a 150-cm antecolic Roux limb with a 25-mm circular pouch-jejunostomy and exclusion of 50 cm of the proximal jejunum.
  • Procedure: Sleeve gastrectomy
    The SG technique consists of a longitudinal resection of the stomach from the angle of His to approximately 5 cm proximal to the pylorus, using a 35 French bougie inserted along the lesser curvature.
Study Arms  ICMJE
  • Active Comparator: Gastric bypass
    Bariatric surgery by gastric bypass (GB)
    Intervention: Procedure: Gastric bypass
  • Experimental: Sleeve gastrectomy
    Bariatric surgery by sleeve gastrectomy (SG)
    Intervention: Procedure: Sleeve gastrectomy
Publications *
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  • Sjöström L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjöström CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93.
  • Salminen P, Helmiö M, Ovaska J, Juuti A, Leivonen M, Peromaa-Haavisto P, Hurme S, Soinio M, Nuutila P, Victorzon M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):241-254. doi: 10.1001/jama.2017.20313.
  • Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
  • Peterli R, Wölnerhanssen BK, Peters T, Vetter D, Kröll D, Borbély Y, Schultes B, Beglinger C, Drewe J, Schiesser M, Nett P, Bueter M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.
  • Angrisani L, Santonicola A, Iovino P, Vitiello A, Zundel N, Buchwald H, Scopinaro N. Bariatric Surgery and Endoluminal Procedures: IFSO Worldwide Survey 2014. Obes Surg. 2017 Sep;27(9):2279-2289. doi: 10.1007/s11695-017-2666-x. Erratum in: Obes Surg. 2017 Jul 5;:.
  • Arterburn D, Gupta A. Comparing the Outcomes of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass for Severe Obesity. JAMA. 2018 Jan 16;319(3):235-237. doi: 10.1001/jama.2017.20449.
  • Climent E, Benaiges D, Pedro-Botet J, Goday A, Solà I, Ramón JM, Flores-LE Roux JA, Checa MÁ. Laparoscopic Roux-en-Y gastric bypass vs. laparoscopic sleeve gastrectomy for morbid obesity: a systematic review and meta-analysis of lipid effects at one year postsurgery. Minerva Endocrinol. 2018 Mar;43(1):87-100. doi: 10.23736/S0391-1977.17.02627-X. Epub 2017 Feb 15. Review.
  • Casajoana A, Pujol J, Garcia A, Elvira J, Virgili N, de Oca FJ, Duran X, Fernández-Veledo S, Vendrell J, Vilarrasa N. Predictive Value of Gut Peptides in T2D Remission: Randomized Controlled Trial Comparing Metabolic Gastric Bypass, Sleeve Gastrectomy and Greater Curvature Plication. Obes Surg. 2017 Sep;27(9):2235-2245. doi: 10.1007/s11695-017-2669-7.
  • Schiavon CA, Bersch-Ferreira AC, Santucci EV, Oliveira JD, Torreglosa CR, Bueno PT, Frayha JC, Santos RN, Damiani LP, Noujaim PM, Halpern H, Monteiro FLJ, Cohen RV, Uchoa CH, de Souza MG, Amodeo C, Bortolotto L, Ikeoka D, Drager LF, Cavalcanti AB, Berwanger O. Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension). Circulation. 2018 Mar 13;137(11):1132-1142. doi: 10.1161/CIRCULATIONAHA.117.032130. Epub 2017 Nov 13. Erratum in: Circulation. 2019 Oct;140(14):e718.
  • Pihlajamäki J, Grönlund S, Simonen M, Käkelä P, Moilanen L, Pääkkönen M, Pirinen E, Kolehmainen M, Kärjä V, Kainulainen S, Uusitupa M, Alhava E, Miettinen TA, Gylling H. Cholesterol absorption decreases after Roux-en-Y gastric bypass but not after gastric banding. Metabolism. 2010 Jun;59(6):866-72. doi: 10.1016/j.metabol.2009.10.004. Epub 2009 Dec 16.
  • Hanusch-Enserer U, Zorn G, Wojta J, Kopp CW, Prager R, Koenig W, Schillinger M, Roden M, Huber K. Non-conventional markers of atherosclerosis before and after gastric banding surgery. Eur Heart J. 2009 Jun;30(12):1516-24. doi: 10.1093/eurheartj/ehp108. Epub 2009 Apr 20.
  • Asztalos BF, Swarbrick MM, Schaefer EJ, Dallal GE, Horvath KV, Ai M, Stanhope KL, Austrheim-Smith I, Wolfe BM, Ali M, Havel PJ. Effects of weight loss, induced by gastric bypass surgery, on HDL remodeling in obese women. J Lipid Res. 2010 Aug;51(8):2405-12. doi: 10.1194/jlr.P900015.
  • Knopp RH, Gitter H, Truitt T, Bays H, Manion CV, Lipka LJ, LeBeaut AP, Suresh R, Yang B, Veltri EP; Ezetimibe Study Group. Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia. Eur Heart J. 2003 Apr;24(8):729-41.
  • Samczuk P, Ciborowski M, Kretowski A. Application of Metabolomics to Study Effects of Bariatric Surgery. J Diabetes Res. 2018 Mar 11;2018:6270875. doi: 10.1155/2018/6270875. eCollection 2018. Review.
  • Ramos-Molina B, Castellano-Castillo D, Alcaide-Torres J, Pastor Ó, de Luna Díaz R, Salas-Salvadó J, López-Moreno J, Fernández-García JC, Macías-González M, Cardona F, Tinahones FJ. Differential effects of restrictive and malabsorptive bariatric surgery procedures on the serum lipidome in obese subjects. J Clin Lipidol. 2018 Nov - Dec;12(6):1502-1512. doi: 10.1016/j.jacl.2018.07.006. Epub 2018 Jul 25.
  • Buchwald H, Rudser KD, Williams SE, Michalek VN, Vagasky J, Connett JE. Overall mortality, incremental life expectancy, and cause of death at 25 years in the program on the surgical control of the hyperlipidemias. Ann Surg. 2010 Jun;251(6):1034-40. doi: 10.1097/SLA.0b013e3181deb4d0.
  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):e285-e350. doi: 10.1016/j.jacc.2018.11.003. Epub 2018 Nov 10. Erratum in: J Am Coll Cardiol. 2019 Jun 25;73(24):3237-3241.
  • Rubino F, Kaplan LM, Schauer PR, Cummings DE; Diabetes Surgery Summit Delegates. The Diabetes Surgery Summit consensus conference: recommendations for the evaluation and use of gastrointestinal surgery to treat type 2 diabetes mellitus. Ann Surg. 2010 Mar;251(3):399-405. doi: 10.1097/SLA.0b013e3181be34e7. Review.
  • Ciurana Misol R, Franzi Sisó A, García Cerdán MR, Ríos Rodríguez MA, Ramos Blanes R, Solanas Saura P, et al. Guies de pràctica clínica. Colesterol i risc coronari. General Catalunya Inst Català de la Salut. 2009;1-131. Available from: http://www.gencat.cat/ics/professionals/guies/docs/material_docent_colesterol.pdf
  • Buse JB, Caprio S, Cefalu WT, Ceriello A, Del Prato S, Inzucchi SE, McLaughlin S, Phillips GL 2nd, Robertson RP, Rubino F, Kahn R, Kirkman MS. How do we define cure of diabetes? Diabetes Care. 2009 Nov;32(11):2133-5. doi: 10.2337/dc09-9036.
  • Marrugat J, D'Agostino R, Sullivan L, Elosua R, Wilson P, Ordovas J, Solanas P, Cordón F, Ramos R, Sala J, Masiá R, Kannel WB. An adaptation of the Framingham coronary heart disease risk function to European Mediterranean areas. J Epidemiol Community Health. 2003 Aug;57(8):634-8.
  • Hutter MM, Schirmer BD, Jones DB, Ko CY, Cohen ME, Merkow RP, Nguyen NT. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg. 2011 Sep;254(3):410-20; discussion 420-2. doi: 10.1097/SLA.0b013e31822c9dac.
  • Climent E, Benaiges D, Flores-Le Roux JA, Ramón JM, Pedro-Botet J, Goday A. Changes in the lipid profile 5 years after bariatric surgery: laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2018 Aug;14(8):1099-1105. doi: 10.1016/j.soard.2018.05.006. Epub 2018 May 19.
  • Benaiges D, Goday A, Ramon JM, Hernandez E, Pera M, Cano JF; Obemar Group. Laparoscopic sleeve gastrectomy and laparoscopic gastric bypass are equally effective for reduction of cardiovascular risk in severely obese patients at one year of follow-up. Surg Obes Relat Dis. 2011 Sep-Oct;7(5):575-80. doi: 10.1016/j.soard.2011.03.002. Epub 2011 Mar 17.
  • Benaiges D, Goday A, Flores-Le Roux JA, Fitó M, Pozo O, Rodríguez-Morató J, Serra C, Pera M, Llauradó G, Climent E, Castañer O, Ramon JM, Pedro-Botet J. Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol. BMJ Open. 2020 Sep 10;10(9):e037712. doi: 10.1136/bmjopen-2020-037712.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) ≥40 or BMI ≥35 kg/m2 with a significant obesity related comorbidities.
  • Age 18 - 60 years.
  • Previous successfully instituted and supervised but failed adequate diet and exercise program.
  • Elevated LDL cholesterol defined as LDL cholesterol concentration >130 mg/dL or treatment with cholesterol-lowering drugs.

Exclusion Criteria:

  • BMI >60 kg/m2.
  • Previous BS.

  • Exclusion criteria for BS:

    • Significant psychiatric disorder.
    • Severe eating disorder, active alcohol or substance abuse.
    • Contraindications for major abdominal surgery.
    • Active gastric ulcer disease.
    • Severe hepatic diseases.
    • Pregnancy or breastfeeding.

  • Cases in whom SG or GB are preferred:

    • Severe symptomatic gastro esophageal reflux disease despite medication.
    • Large hiatal hernia.
    • Expected dense adhesions at the level of the small bowel.
    • Need for endoscopic follow-up of the duodenum, history of inflammatory bowel disease.
    • History of renal transplantation in which drug malabsorption can be caused with a GB.

  • Cholesterol lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up. Cases in whom perioperative statins withdrawn cannot be adequate will be excluded:

    • Established cardiovascular disease or subclinical cardiovascular disease (atheroma plaque detection in carotid ultrasonography exam) in which LDL cholesterol objectives are more aggressive or statins can be prescribed independently of LDL cholesterol levels.
    • LDL cholesterol >190 mg/dL or history of familial hypercholesterolemia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Benaiges Boix, Dr +34932483902 DBenaiges@parcdesalutmar.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975478
Other Study ID Numbers  ICMJE 2019/8471/I
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Benaiges Boix, Dr Hospital del Mar (Barcelona, Spain)
PRS Account Parc de Salut Mar
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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